Pharmacogenetics: Development Issues and Solutions for Safe and Effective Medicines

Abstract

PharmacogenomicsVol. 7, No. 2 Conference ScenePharmacogenetics: Development Issues and Solutions for Safe and Effective MedicinesHans Peter Arnold & Duncan McHaleHans Peter Arnold† Author for correspondenceSearch for more papers by this author & Duncan McHaleSearch for more papers by this authorPublished Online:3 Mar 2006https://doi.org/10.2217/14622416.7.2.149AboutSectionsView ArticleView Full TextPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareShare onFacebookTwitterLinkedInReddit View articleBibliography1 Gilbert J, Henske P, Singh A: Rebuilding Big Pharma’s Business Model. In: In vivo, the Business & Medicine Report. Windhover Information, Inc., CT, USA, Vol. 21, No. 10 (2003).Google Scholar2 Arnold HP, Hall S: Pharmacogenomics and Clinical R&D. Pharmacogenomics6(8), 801–806 (2005).Link, Google Scholar101 Position Paper on terminology in Pharmacogenetics. The European Agency for the Evaluation of Medicinal Products (EMEA), Committee for Medicinal Products for Human Use (CHMP), November 21, 2002, EMEA/CHMP/3070/01. www.emea.eu.int/pdfs/human/press/pp/307001en.pdfGoogle Scholar102 Innovation or Stagnation? Challenge and Opportunity on the Critical Path to New Medicinal Products. Department of Health and Human Services. Food and Drug Administration (FDA), March 2004. www.fda.gov/oc/initiatives/criticalpath/ whitepaper.pdf.Google Scholar103 DIA/EMEA/CIOMS/EFPIA Joint Workshop Pharmacogenetics: Development Issues and Solutions for Safe and Effective Medicines brochure. www.diahome.org/Content/Events/05116.pdfGoogle Scholar104 Italian Proposed Guidelines for the Evaluation of Pharmacogenetic Research. English translation. http://sigu.univr.it/sigu/html/documenti/LGFG_eng.pdfGoogle Scholar105 Pharmacogenetics: Ethical Issues. Nuffield Council on Bioethics, September 2003. www.nuffieldbioethics.org/fileLibrary/pdf/pharmacogenetics_report.pdf.Google Scholar106 Pharmacogenetics. Towards improving treatment with medicines. ISBN 92 9036 078 X. www.cioms.ch/frame_pharmacogenetics_febr_2005.htm.Google Scholar107 Guidance for Industry: Pharmacogenomic Data Submissions. US Department of Health and Human Services, Food and Drug Administration, March 2005. www.fda.gov/cder/guidance/6400fnl.pdfGoogle Scholar108 Guideline on Pharmacogenetics Briefing Meetings. The European Agency for the Evaluation of Medicinal Products (EMEA), Committee for Medicinal Products for Human Use (CHMP), March 17, 2005. EMEA/CHMP/20227/2004. www.emea.eu.int/pdfs/human/pharmacogenetics/2022704en.pdfGoogle Scholar109 Concept Paper on the Development of a Guideline on Biobanks Issues Relevant to Pharmacogenetics. The European Agency for the Evaluation of Medicinal Products (EMEA), Committee for Medicinal Products for Human Use (CHMP), March 17, 2005, EMEA/CHMP/6806/2005. www.emea.eu.int/pdfs/human/pharmacogenetics/680605en.pdfGoogle Scholar110 Application and validation of genomic biomarkers for use in drug development and regulatory submissions workshop brochure. www.diahome.org/Content/Events/ 05020.pdfGoogle Scholar111 Drug–Diagnostic Co-Development Concept Paper (Draft). Department of Health and Human Services (HHS), Food and Drug Administration (FDA) April 2005. www.fda.gov/cder/genomics/pharmacoconceptfn.pdf.Google Scholar112 Perlegen Sciences Genotype Browser. http://genome.perlegen.comGoogle Scholar113 Mandate, Objectives and Rules of Procedure for the CHMP Pharmacogenetics Working Party. The European Agency for the Evaluation of Medicinal Products (EMEA), Committee for Medicinal Products for Human Use (CHMP), February 17, 2002. EMEA/CHMP/101592/2004. www.emea.eu.int/pdfs/human/pharmacogenetics/10159204en.pdfGoogle ScholarFiguresReferencesRelatedDetailsCited ByThe Promise of Individualized Therapy15 March 2010EU policies in personalized medicine-related technologiesSibylle Gaisser, Etienne Vignola-Gagné, Bärbel Hüsing, Christien Enzing, Tessa van der Valk23 December 2008 | Personalized Medicine, Vol. 6, No. 1Perspectives on the Current State of Pharmacogenomics in Drug DevelopmentYAKUGAKU ZASSHI, Vol. 129, No. 1Evaluación económica en la era de la farmacogenética y farmacogenómica: ¿un rayo de luz en la oscuridad?Medicina Clínica, Vol. 127, No. 17 Vol. 7, No. 2 Follow us on social media for the latest updates Metrics Downloaded 473 times History Published online 3 March 2006 Published in print March 2006 Information© Future Medicine LtdNoteAlthough there are explicit definitions available [101], ‘pharmacogenetics’ is often used interchangeably with the term ‘pharmacogenomics', and since many of the speakers did not differentiate between these two terms in their presentations, these terms are used interchangeably also in this article. DisclosureBoth authors are members of the ad hoc pharmacogenetic working group of the European Federation of Pharmaceutical Industries and Associations (EFPIA).PDF download